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DSM, Crucell increasing PER.C6 yields

33 Posts, Pagina: « 1 2 | Laatste
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1
Natuurlijk is er een milestone ontvangen van Sanofi na afloop van fase 1. Alleen niet gemeld.
En zou er dan wéééééér een milestone moeten komen bij de start van fase 2???? Onzin!!
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1
quote:

oudje schreef:


Natuurlijk is er een milestone ontvangen van Sanofi na afloop van fase 1. Alleen niet gemeld.
En zou er dan wéééééér een milestone moeten komen bij de start van fase 2???? Onzin!!

Let's see, no milestone for completion of phase I, and no milestone for the start of phase II, but you claim there is a milestone. And Crucell, using the "Cone of Silence" from Get Smart, claims it is not allowed to ever say anything about milestones...ever. Which in this case is easy, because there isn't one.

Oudje, call Ron and Leon and tell them you need more money to so shamelessly pump this stock. Since Ron and Leon have shown such lax moral ethics, they might agree to throw an extra couple hundred a month your way. Then you can at least be an Overpaid Pumper.
gogogoo
1
quote:

ron banged schreef:


[quote=oudje]
Natuurlijk is er een milestone ontvangen van Sanofi na afloop van fase 1. Alleen niet gemeld.
En zou er dan wéééééér een milestone moeten komen bij de start van fase 2???? Onzin!!
[/quote]
Let's see, no milestone for completion of phase I, and no milestone for the start of phase II, but you claim there is a milestone. And Crucell, using the "Cone of Silence" from Get Smart, claims it is not allowed to ever say anything about milestones...ever. Which in this case is easy, because there isn't one.

Oudje, call Ron and Leon and tell them you need more money to so shamelessly pump this stock. Since Ron and Leon have shown such lax moral ethics, they might agree to throw an extra couple hundred a month your way. Then you can at least be an Overpaid Pumper.


Ron, you are out of line!
wilb52
0
quote:

ron banged schreef:


[quote=oudje]
Natuurlijk is er een milestone ontvangen van Sanofi na afloop van fase 1. Alleen niet gemeld.
En zou er dan wéééééér een milestone moeten komen bij de start van fase 2???? Onzin!!
[/quote]
Let's see, no milestone for completion of phase I, and no milestone for the start of phase II, but you claim there is a milestone. And Crucell, using the "Cone of Silence" from Get Smart, claims it is not allowed to ever say anything about milestones...ever. Which in this case is easy, because there isn't one.

Oudje, call Ron and Leon and tell them you need more money to so shamelessly pump this stock. Since Ron and Leon have shown such lax moral ethics, they might agree to throw an extra couple hundred a month your way. Then you can at least be an Overpaid Pumper.



Ronnie , I agree: You have the chart on your site.
Again , the chart breaks downward.
Help help help, we can't swimm.
Cybertom
1
Hier begint maag werkelijk van te draaien.....wat een inspelen op de koersontwikkeling van vandaag, bah!
wilb52
1
quote:

Cybertom schreef:


Hier begint maag werkelijk van te draaien.....wat een inspelen op de koersontwikkeling van vandaag, bah!


Niet bepaald inspelen op de koersontwikkeling, dan heb je het verkeerd.
De totale markt staat wederom op een draaipunt.
Als jij het NIET vreemd vindt dat de koers wederom fors onderuit gaat .
10% eraf betekent niets?

En voor de niet? wetenden : er zijn weer turbo's , speeders van 7, nl 7,8,9,10,11 allen long , en geen shorts erbij.
Zegt dat dan niet voldoende?
aossa
1
www.dsm.com/en_US/downloads/invest/an...

Embracing the Future

DSM Pharmaceutical Products and Crucell have jointly developed the XD™ process, involving a highdensity cell culture with (human) PER.C6® cells.
This innovation is based on clever design of the cell-culture processing equipment and can lead to a paradigm shift in the manufacturing of complex,
costly biopharmaceuticals such as recombinant proteins including monoclonal antibodies. This achievement represents another step forward in the establishment of the PER.C6® protein manufacturing platform, jointly developed by Crucell and DSM, as the leading (human) technology in the industry and will make biopharmaceuticals cheaper and therefore available to a much wider patient population than today. In addition, the human PER.C6® cells have the potential to bestow beneficial properties on the
biopharmaceuticals they are programmed to produce, and minimize side effects potentially associated ith the use of non-human cell systems. In 2007, a yield of 13 grams per liter was achieved for XD™ and PER.C6®.

DSM Biologics is a provider of biopharmaceutical manufacturing technology and services. DSM iologics and Crucell NV have co-exclusive rights to license the highproducing PER.C6 ® technology platform to the biopharmaceutical industry as a production platform for recombinant proteins and monoclonal antibodies. DSM Biologics operates a manufacturing facility in Groningen, the Netherlands, approved by the US Food and Drug Administration (FDA) for mammalian-cell-based ontract manufacturing and PER.C6 ® process support. DSM Biologics also offers microbial-cell-based contract manufacturing services through its operations in Capua, Italy.
Anti-Infectives R&D successfully scaled up cophenolate mofetil. Registration batches were produced and first sales realized. Pharmaceutical Products R&D developed the XD™ process , involving a high-cell-density cell culture with human PER.C6® cells.

DSM Biologics’ activities were centered on providing manufacturing services for new and existing customers from the facility in Groningen (Netherlands) and expanding the PER.C6 ® Development Center in Boston, United States with joint-venture partner Crucell NV.
The number of new manufacturing projects increased
compared with 2006. DSM Biologics also announced the
innovative XD ™ process . This cell-based manufacturing process tailored to the PER.C6 ® technology platform is capable of producing much higher yields in manufacturing, and can create a breakthrough in biopharmaceutical manufacturing.
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(WO/2008/006494) IMPROVED PROCESS FOR THE CULTURING OF CELLS

Applicants: DSM IP ASSETS B.V. [NL/NL];
Agent: BREEPOEL, Peter, Maria; DSM Intellectual Property

Abstract: The invention relates to a process for the culturing of cells, preferably E1-immortalized HER cells, more preferably PER.C6 cells in a reactor in suspension in a cell culture medium, wherein the cells produce a biological substance, preferably an antibody, wherein at least one cell culture medium component is fed to the cell culture and wherein the cell culture comprising the cells, the biological substance and cell culture medium is circulated over a separation system and wherein the separation system separates the biological substance from substances having a lower molecular weight than the biological substance and wherein the biological substance is retained in or fed back into the reactor. Preferably part of the substances of lower molecular weight is continuously removed from the cell culture.
www.wipo.int/patentscopedb/en/fetch.j...
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0
Mooi linkje go, even wennen aan de DSM-namen!

The invention relates to a process for the culturing of cells in a reactor in suspension in a cell culture medium. Such a process is for example known from WO04/099396. Herein it is described how the cell density of the cell culture and the yield of the desired biological material can be improved by optimizing the growth conditions in a fed-batch process. Furthermore, WO05/095578 discloses a process for the culturing of cells by continuous perfusion culturing of a cell culture comprising cell culture medium and cells, wherein cell culture medium is added to the cell culture, the cell culture is circulated over a filter module comprising hollow fibers resulting in an outflow of liquid having a lower cell density than the cell culture, and the flow within the filter module is an alternating tangential flow, wherein the cells produce a biological substance. In the examples of WO05/095578 it is shown that 0.9 g/L/day product is produced, corresponding to a product concentration in the outflow of approximately 0.3 g/L.

The larger the volume of liquid containing the biological substance, the more laborious becomes the purification of the biological substance. The concentration of biological substance obtained is not that high in the processes as disclosed in WO04/099396 and WO05/095578. Therefore, downstream processing of this biological substance is cumbersome, because the biological substance needs to be concentrated before further purification steps are applied or large volumes of less concentrated biological substance need to be purified. Furthermore, the culturing of cells at lower cell densities results in lower volumetric productivity and therefore requires larger and/or more culturing vessels and thus higher investments in equipment for a given production level.

Therefore, it is the object of the invention to provide a process wherein the product is obtained from the cell culture in higher concentrations.

A further object of the present invention is to enable culturing of the cells and production of the biological material during an extended period. These objects are achieved by a process for the culturing of cells in a reactor in suspension in a cell culture medium, wherein the cells produce a biological substance, wherein at least one cell culture medium component is fed to the cell culture and wherein the cell culture comprising the biological substance and cell culture is circulated over a separation system and wherein the separation system separates

the biological substance from substances having a lower molecular weight than the biological substance and wherein the biological substance is retained in or fed back into the reactor.

For example, the invention relates to a process for the culturing of cells in a reactor in a cell culture medium, wherein the cells produce a biological substance, wherein nutrients and/or cell culture medium is/are fed to the reactor and wherein the cell culture comprising the cells and the cell culture medium is circulated over a filter having a pore size or molecular weight cut off of between 5 and 50OkD. It has been found that by using a separation system that separates the biological substance from substances having a lower molecular weight than the biological substance, the biological substance can be accumulated in the cell culture in higher concentrations.

Hence, the present invention differs form the cell culturing described in the prior art in that it allows for accumulation of the desired biological material together with the cell mass.

In a preferred embodiment of the present invention part of the substances of lower molecular weight are continuously removed from the cell culture.

An additional advantage of the process of the present invention is that higher viable cell concentration can be reached as compared to for example batch or fed-batch processes. Furthermore, the production time - the period during which the cells produce the biological substance - can be extended compared to for example batch or fed-batch processes. Also, as compared to a batch or fed-batch process, it is possible to use a smaller reactor. Use of smaller reactors is of advantage as this reduces the equipment and facility related investments. Also, higher concentrations of the biological substance may be obtained in shorter times.

It was found that it was possible to obtain high concentrations of biological substance within the reactor without sharply decreasing the cell viability and hence without limiting the production time. The person skilled in the art would have expected that the product inhibition, i.e. inhibition of production of the biological substance by the biological substance itself or inhibition by other macromolecules produced by the cell (such as for instance host cell proteins, enzymes or cellular debris), would occur. Furthermore, it was found that the accumulation of the desired biological material does not impair the function of the separation system. The process of the present invention provides a considerable
advantage in terms of cell density, product concentration in the cell culture and extended culturing period as compared to the processes according to WO05/095578 and WO04/099396. As a result the present process results in an improved production of the desired biological material. Cells which can be used to produce the biological substance are in principle all cells known to the person skilled in the art, which have the ability to produce a biological product. The cells may be eukaryotic, for example, filamentous fungi, for example Aspergillus niger, Aspergillus oryzae, Trichoderma reesei, Penicillium chrysogenum, yeasts, for example Saccharomyces cerevisiae, Kluyveromyces lactis, Phaffia rhodozyma, yeast from the genus Pichia, for example Pichia pastoris or prokaryotic, for instance Escherichia coli, Bacillus sp, for example B. licheniformis, B. subtilis, B. amyloliquefaciens, B. alkalophilus, Streptomyces sp. , Corynebacterium glutamicum, Pseudomonas sp. Examples of eukaryotic cells are for example also described in Chu, L., Robinson, D. K., (2001 ) Curr. Opinion Biotechn., vol. 12, p. 180-187. Preferably, the cells that are used in the process of the present invention are animal cells, in particular mammalian cells. Examples of mammalian cells include CHO (Chinese Hamster Ovary) cells, hybridomas, BHK (Baby Hamster Kidney) cells, myeloma cells, human cells, for example HEK-293 cells, human lymphoblastoid cells, E1 immortalized HER cells, mouse cells, for example NSO cells. More preferably, E1 immortalized HER cells are used, most preferably PER.C6 cells.
josti5
0
Oeps flosz, had je in boosheid en teleurstelling IEX er helemaal aan gegeven?

IEX: strijk over je hart, en maak flosz weer flosz!

Welcome back, anyway: het blijft inderdaad moeilijk kiezen, zeker gezien die verrekte internet-anonimiteit met telkens weer opduikende 'nieuwe' aliassen en betaalde 'leden, in dienst van...???'?

In luttele jaren tijd is het er niet beter op geworden op fora als deze, integendeel.

Maaarrr: wij zullen doorgaan!!!

aossa
0
quote:

josti5 schreef:

Maaarrr: wij zullen doorgaan!!!

Vooral omdat recent ook Brus wat heeft opgevist aan braderieprijzen. (+18076 stuks à EUR 9,1)
flosz
0
quote:

josti5 schreef:


Oeps flosz, had je in boosheid en teleurstelling IEX er helemaal aan gegeven?

IEX: strijk over je hart, en maak flosz weer flosz!





Hé J.
Klopt.
Is inmiddels gelukt(naam was in eerste instantie niet beschikbaar), ik weet nu ook dat het daadwerkelijk mogelijk is om via 2 "aliJasses" lid te zijn en in te loggen vanaf één comp./IP adr. Dus je hebt helemaal gelijk..., profjes kunnen dit ook met tig "aliJasses".
Gr.

Linkje bij post aossa:
crucell.yourbb.nl/viewtopic.php?f=5&t...
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